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QSYMIA Drug Profile

When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Summary for QSYMIA

US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	8
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QSYMIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QSYMIA
DailyMed Link:	QSYMIA at DailyMed

Drug patent expirations by year for QSYMIA

Generic Entry Opportunity Date for QSYMIA

Generic Entry Date for QSYMIA^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up NDA: 022580 Dosage: CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for QSYMIA

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors
Physiological Effect	Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for QSYMIA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Expired US Patents for QSYMIA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	➤ Sign Up	➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	➤ Sign Up	➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	➤ Sign Up	➤ Sign Up
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for QSYMIA

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Extended-release Capsules	3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg	➤ Subscribe	➤ Sign Up

International Patents for QSYMIA

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Country	Document Number	Estimated Expiration
South Korea	20110042280	➤ Sign Up
Hong Kong	1213489	➤ Sign Up
European Patent Office	2167064	➤ Sign Up
Spain	2542891	➤ Sign Up
Australia	5489600	➤ Sign Up
Cyprus	1106974	➤ Sign Up
Country	Document Number	Estimated Expiration

Summary for QSYMIA

Generic Entry Opportunity Date for QSYMIA

Pharmacology for QSYMIA

Paragraph IV (Patent) Challenges for QSYMIA

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